(178 days)
Not Found
No
The document describes pressure transducers that convert physiological signals to electrical signals. There is no mention of AI, ML, or any learning algorithms used in the device's operation or data processing.
No
The device is used for monitoring intravascular pressure and cardiac output, not for treating a condition.
Yes
The device measures physiological signals (intravascular pressure and cardiac output) to provide information used for patient monitoring and clinical assessment, which falls under the definition of diagnosis.
No
The device description explicitly states that the sensors are constructed from disposable pressure transducers that convert a physiological signal to an electrical signal, indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "intravascular pressure monitoring" and "to measure cardiac output" using arterial pressure. This involves directly measuring physiological parameters within the body.
- Device Description: The device is described as a "disposable pressure transducer" that converts a "physiological signal (or mechanical pressure) to an electrical signal." This is consistent with a device that interacts directly with the patient's circulatory system.
- Anatomical Site: The anatomical site is "Intravascular," meaning within blood vessels.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are specifically designed to perform tests on samples taken from the human body in vitro (in a test tube or other artificial environment). This device operates in vivo (within the living body).
N/A
Intended Use / Indications for Use
The FloTrac sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. They are intended to be used in adult patients.
The FloTrac Jr sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. The FloTrac Jr sensor is indicated for use in pediatric patients >= 12 years of age.
The Acumen IQ sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. They are intended to be used in adult patients.
The VolumeView sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output.
Product codes
DRS
Device Description
The FloTrac, Acumen IQ, and VolumeView sensors are constructed from two disposable pressure transducers that convert a physiological signal (or mechanical pressure) to an electrical signal that is transmitted through the cable to the patient monitor. The sensors have a straight, flow-through design in which fluid is passed directly across the pressure sensor. The sensors are comprised of a pressure sensitive silicon chip with two electrodes for excitation voltage and two electrodes for signal output. A polycarbonate housing with an integral stopcock at one end, and an integral flush device at the other end, encloses the sensors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intravascular
Indicated Patient Age Range
Adult patients (FloTrac sensor, Acumen IQ sensor, VolumeView sensor), pediatric patients >= 12 years of age (FloTrac Jr sensor)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing was performed in accordance with ISO 10993-1: 2018 – Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, and FDA guidance document, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", issued on September 4, 2020.
Performance verification was performed in accordance with Edwards' current design requirements. In addition, shelf-life and sterilization validations have been performed to existing specifications.
All testing met the existing predetermined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2850 Extravascular blood pressure transducer.
(a)
Identification. An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.(b)
Classification. Class II (performance standards).
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March 21, 2025
Edwards Lifesciences, LLC Aeree Lee Sr Manager, Regulatory Affairs One Edwards Way Irvine, California 92614
Re: K242909
Trade/Device Name: FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors Regulation Number: 21 CFR 870.2850 Regulation Name: Extravascular blood pressure transducer Regulatory Class: Class II Product Code: DRS Dated: February 21, 2025 Received: February 21, 2025
Dear Aeree Lee:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Robert T. for Kazmierski -S LCDR Stephen Browning Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
K242909
Device Name
FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors
Indications for Use (Describe)
The FloTrac sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. They are intended to be used in adult patients.
The FloTrac Jr sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. The FloTrac Jr sensor is indicated for use in pediatric patients ≥ 12 years of age.
The Acumen IQ sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. They are intended to be used in adult patients.
The VolumeView sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output.
Type of Use (Select one or both, as applicable)
× | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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| FloTrac sensors, Acumen IQ sensors, and VolumeView sensors | |||
|---|---|---|---|
| 510(k) Submitter | Edwards Lifesciences, LLC | ||
| One Edwards Way | |||
| Irvine, CA 92614 | |||
| Contact Person | Primary Contact | Secondary Contact | |
| Aeree Lee | Karen O'Leary | ||
| Sr. Manager, Regulatory Affairs | Sr. Director, Regulatory Affairs | ||
| Edwards Lifesciences LLC | Edwards Lifesciences LLC | ||
| One Edwards Way, | One Edwards Way, | ||
| Irvine, CA USA, 92614 | Irvine, CA USA, 92614 | ||
| Tel.: (949) 250-5155 | Tel.: (949) 250-0715 | ||
| Email: aeree_lee@edwards.com | Email: karen_oleary@edwards.com | ||
| Date Prepared | February 21, 2025 | ||
| Trade Name | FloTrac sensor | ||
| FloTrac Jr sensor | |||
| Acumen IQ sensor | |||
| VolumeView sensor | |||
| Regulation | |||
| Number / Name | 21 CFR §870.2850 / Extravascular blood pressure transducer | ||
| Product Code | DRS | ||
| Regulation Class | Class II | ||
| Predicate Devices | FloTrac, Acumen IQ, and VolumeView sensosr: K152980 (cleared January 19, 2016) | ||
| FloTrac Jr sensor: K231248 (cleared September 21, 2023) | |||
| Device | |||
| Description | The FloTrac, Acumen IQ, and VolumeView sensors are constructed from two | ||
| disposable pressure transducers that convert a physiological signal (or | |||
| mechanical pressure) to an electrical signal that is transmitted through the cable | |||
| to the patient monitor. The sensors have a straight, flow-through design in | |||
| which fluid is passed directly across the pressure sensor. The sensors are | |||
| comprised of a pressure sensitive silicon chip with two electrodes for excitation | |||
| voltage and two electrodes for signal output. A polycarbonate housing with an | |||
| integral stopcock at one end, and an integral flush device at the other end, encloses the sensors. | |||
| Indications for | |||
| Use | The FloTrac sensor is indicated for use in intravascular pressure monitoring. It | ||
| is also indicated for use with the Edwards arterial pressure based cardiac output | |||
| monitoring devices or hardware to measure cardiac output. They are intended to | |||
| be used in adult patients. | |||
| The FloTrac Jr sensor is indicated for use in intravascular pressure monitoring. | |||
| It is also indicated for use with the Edwards arterial pressure based cardiac | |||
| output monitoring devices or hardware to measure cardiac output. The FloTrac | |||
| Jr sensor is indicated for use in pediatric patients ≥ 12 years of age. | |||
| FloTrac sensors, Acumen IQ sensors, and VolumeView sensors | The Acumen IQ sensor is indicated for use in intravascular pressure monitoring. | ||
| It is also indicated for use with the Edwards arterial pressure based cardiac | |||
| output monitoring devices or hardware to measure cardiac output. They are | |||
| intended to be used in adult patients. |
The VolumeView sensor is indicated for use in intravascular pressure
monitoring. It is also indicated for use with the Edwards arterial pressure based
cardiac output monitoring devices or hardware to measure cardiac output. |
| | | Comparative
Analysis | The subject devices are identical to the predicate devices in terms of the
intended use, indications for use, and technological characteristics, except for
the changed pressure tubing and IV set component materials. The differences
do not raise any new concerns of safety and effectiveness. The provided risk
analysis and performance verification testing demonstrates the subject devices
are substantially equivalent to the predicates. |
| | | Device Testing | Biocompatibility testing was performed in accordance with ISO 10993-1: 2018
– Biological evaluation of medical devices – Part 1: Evaluation and testing
within a risk management process, and FDA guidance document, Use of
International Standard ISO 10993-1, "Biological evaluation of medical devices
– Part 1: Evaluation and testing within a risk management process", issued on
September 4, 2020.
Performance verification was performed in accordance with Edwards' current
design requirements. In addition, shelf-life and sterilization validations have
been performed to existing specifications.
All testing met the existing predetermined acceptance criteria. |
| | | Conclusion | Based on the performance testing and the technological characteristics, the
FloTrac sensors, Acumen IQ sensors, and VolumeView sensors meet the
established performance criteria and are substantially equivalent to the
predicate. |
510(K) SUMMARY
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